Acthar Gel for Active Systemic Lupus Erythematosus (SLE)
NCT ID: NCT02953821
Last Updated: 2020-08-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
172 participants
INTERVENTIONAL
2016-12-16
2019-10-25
Brief Summary
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The doctor will assign eligible patients to one of two groups (like flipping a coin).
Participants will receive the treatment assigned to their group for 24 weeks:
* Acthar Gel
* Placebo Gel, which looks like Acthar Gel, but has no medicine in it.
The doctor or his staff will take measurements and ask questions to:
* see how well the gel is working
* see how safe it is for patients with SLE
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Acthar Gel
Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks
Acthar Gel
1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)
Placebo Gel
Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks
Placebo Gel
1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)
Interventions
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Acthar Gel
1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)
Placebo Gel
1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a diagnosis of SLE according to 4 of the American College of Rheumatology revised criteria
* Have active SLE
* Have moderate to severe rash and/or arthritis as demonstrated by BILAG-2004 score A or B in the mucocutaneous and/or musculoskeletal body systems at both Screening and Randomization Visits
* Have a documented history or screening result of
1. positive antinuclear antibody (ANA), OR
2. elevated anti-dsDNA or extractable nuclear antigen (ENA) antibodies
* Have been on prednisone (or prednisone equivalent) before the screening visit:
1. at least 8 weeks, and
2. at a stable dose of 7.5 mg to 30 mg for at least 4 weeks
Exclusion Criteria
* Has a history of sensitivity to adrenocorticotropic hormone (ACTH) preparations or porcine products
* Has active lupus nephritis
* Has active central nervous system (CNS) manifestations of SLE
18 Years
ALL
No
Sponsors
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Mallinckrodt
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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C.V. Mehta MD Medical Corporation
Hemet, California, United States
Inland Rheumatology Clinical Trials
Upland, California, United States
Center for Rheumatology Immunology and Arthritis
Fort Lauderdale, Florida, United States
San Marcus Research Clinic
Miami, Florida, United States
Advanced Pharma CR
Miami, Florida, United States
Millennium Research
Ormond Beach, Florida, United States
Office of George Timothy Kelly MD
Las Vegas, Nevada, United States
NewYork-Presbyterian Columbia University Medical Center
New York, New York, United States
DJL Clinical Research
Charlotte, North Carolina, United States
Paramount Medical Research & Consulting
Middleburg Heights, Ohio, United States
Arthritis & Rheumatology Center of Oklahoma
Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
West Tennessee Physicians' Alliance
Jackson, Tennessee, United States
Office of Ramesh C. Gupta, MD
Memphis, Tennessee, United States
Accurate Clinical Research
Houston, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Aprillus Asistencia e Investigación
Buenos Aires, , Argentina
Consultorios Médicos Dr. Catalán Pellet
Buenos Aires, , Argentina
Centro Medico Privado de Reumatología
San Miguel de Tucumán, , Argentina
Biomedica Research Group
Santiago, , Chile
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
IBIOMED Research Unit Aguascalientes
Aguascalientes, , Mexico
Centro Especializado en Investigación Clínica
Boca del Río, , Mexico
Phylasis Clinicas Research S de RL de CV
Cuautitlán Izcalli, , Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, , Mexico
Unidad de Investigación de las Enfermedades Reumáticas
Mexico City, , Mexico
Centro Peninsular de Investigacion Clinica S.C.P.
Mérida, , Mexico
Köhler and Milstein Research
Mérida, , Mexico
Consultorio de Reumatología
México, , Mexico
Centro Integral de Reumatologia
México, , Mexico
Accelerium Clinical Research
Monterrey, , Mexico
Centro de Estudios Clínicos y Especialidades Médicas
Monterrey, , Mexico
SMIQ
Querétaro, , Mexico
Centro de Alta Especialidad en Reumatologia e Investigación del Potosí, SC
San Luis Potosí City, , Mexico
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
Zapopan, , Mexico
Investigaciones Clinicas S.A.C. del Instituto de Ginecologia y Reproduccion
Lima, , Peru
Clinica Vesalio
San Borja, , Peru
Hospital de Apoyo Maria Auxiliadora
San Juán de Miraflores, , Peru
Hospital Nacional Cayetano Heredia
San Martín de Porres, , Peru
Countries
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References
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Askanase AD, Wright D, Zhao E, Zhu J, Bilyk R, Furie RA. Post Hoc Biomarker Analyses from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Repository Corticotropin Injection (Acthar(R) Gel) for Persistently Active Systemic Lupus Erythematosus. Rheumatol Ther. 2021 Dec;8(4):1871-1886. doi: 10.1007/s40744-021-00351-7. Epub 2021 Sep 3.
Askanase AD, Wan GJ, Panaccio MP, Zhao E, Zhu J, Bilyk R, Furie RA. Patient-Reported Outcomes from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Repository Corticotropin Injection (Acthar(R) Gel) for Persistently Active Systemic Lupus Erythematosus. Rheumatol Ther. 2021 Mar;8(1):573-584. doi: 10.1007/s40744-021-00294-z. Epub 2021 Mar 9.
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Askanase AD, Zhao E, Zhu J, Bilyk R, Furie RA. Repository Corticotropin Injection for Persistently Active Systemic Lupus Erythematosus: Results from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Rheumatol Ther. 2020 Dec;7(4):893-908. doi: 10.1007/s40744-020-00236-1. Epub 2020 Sep 29.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MNK14304067
Identifier Type: -
Identifier Source: org_study_id
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